Z-0977-2015 Class II Terminated
FDA device recall Z-0977-2015 was initiated by SpineFrontier, Inc. on Dec 19, 2014 and is designated Class II. Reason for recall: A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument. The recall status is terminated (terminated Jan 11, 2016). Affected quantity: 4 devices.
Recall details
- Product Type
- Devices
- Report Date
- Jan 21, 2015
- Initiation Date
- Dec 19, 2014
- Termination Date
- Jan 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices
Product description
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Reason for recall
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Distribution pattern
Nationwide Distribution including TX, OH, VA, and Washington, DC.
Code information
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0977-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026